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Last updated on April 17, 2014 at 1:21 EDT

EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia

November 9, 2010

LANGHORNE, Pennsylvania and OXFORD, England, November 9, 2010
/PRNewswire/ — EUSA Pharma, a transatlantic specialty pharmaceutical company
focused on oncology, oncology supportive care and critical care, today
announced that it has submitted a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) for ERWINASE(R) (L-asparaginase
derived from Erwinia chrysanthemi) for use in the treatment of acute
lymphoblastic leukemia in patients with hypersensitivity to E. coli-derived
asparaginase. ERWINASE is currently approved in a number of countries,
including Canada, the UK and several European Union member states, and is
supplied in the United States under a treatment IND.

EUSA Pharma submitted its ERWINASE BLA on a rolling basis, following
receipt of Fast Track designation from the FDA. The completed BLA submission
requests Priority Review status, which can reduce the regulatory assessment
period to six months for major treatment advances. Additionally, the FDA has
awarded ERWINASE orphan drug designation, which provides a seven-year period
of market exclusivity upon approval.

Dr Tim Corn, EUSA Pharma’s Chief Medical Officer, commented, “The
submission of our ERWINASE BLA is a major step towards our goal of making
this important therapy available as rapidly as possible. Many children with
acute lymphoblastic leukemia develop allergy to current asparaginase
products, and ERWINASE provides a key therapeutic alternative for this
gravely ill group in several countries around the world. By applying for
Priority Review status, we hope to shorten the period before EUSA can launch
ERWINASE in the U.S., and reduce the time before physicians can provide this
potentially life-saving drug to those who may benefit from it.”

“Completing the BLA filing for ERWINASE marks a major strategic milestone
for EUSA,” said Bryan Morton, EUSA Pharma’s President and Chief Executive
Officer. “Based on new study results and existing clinical experience, we
believe ERWINASE has the potential to enhance the treatment of acute
lymphoblastic leukemia significantly, both in the U.S. and further afield. In
the coming months, EUSA plans to achieve pan-European authorization for
ERWINASE, and our partners are pursuing regulatory approval in Japan and
elsewhere. As a result, ERWINASE has the opportunity to become EUSA’s second
global product, marking the company’s rapid transformation into a leading
player in the specialty oncology field.”

About acute lymphoblastic leukemia

Acute lymphoblastic leukemia (ALL) is the most commonly diagnosed
childhood cancer [1]. ALL predominantly affects children and adolescents, who
account for over 60% of the more than 5,000 new cases diagnosed in the U.S.
each year [2]. ALL treatment is complex, involving a number of stages and
many drugs, and includes asparaginase as an essential component of current
protocols. Pediatric treatment is often highly successful, with remission
rates of over 95% and 75 – 85% of treated children surviving for at least
five years without recurrence of leukemia [1].

About ERWINASE

ERWINASE is an asparaginase enzyme that depletes the level of the amino
acid asparagine in the bloodstream. Asparagine is essential for cell growth,
and its removal from the blood inhibits the growth of cells associated with
acute lymphoblastic leukemia. Asparaginase products are derived from
bacteria, and up to 60% of patients develop antibodies to those produced by
Escherichia coli [3]. ERWINASE, which is produced by Erwinia chrysanthemi, is
immunologically distinct from these therapies and is suitable for patients
with hypersensitivity to E. coli-derived treatments*. The BLA submission for
ERWINASE includes data from a recent study in children with hypersensitivity
to pegylated E. coli asparaginase, which will be presented at the American
Society of Hematology in December 2010.

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical
company focused on in-licensing, developing and marketing late-stage
oncology, oncology supportive care and critical care products. The company
has an established commercial infrastructure in the U.S., a pan-European
presence and a wider distribution network in numerous additional territories.
EUSA currently has a total of 10 specialist hospital products, which are sold
in over 80 countries globally**. These include Erwinase(R) and Kidrolase(R)
for the treatment of acute lymphoblastic leukemia, Caphosol(R) for the
treatment of oral mucositis, a common and debilitating side-effect of
radiation therapy and high dose chemotherapy, Collatamp(R) G, a surgical
implant impregnated with the antibiotic gentamicin, ProstaScint(R) for
imaging the extent and spread of prostate cancer and Quadramet(R) for the
treatment of pain in patients whose cancer has spread to the bones. The
company also has several products in late-stage development.

References

[1] U.S. National Cancer Institute. Childhood acute lymphoblastic
leukemia treatment (PDQ(R)).

[2] U.S. National Cancer Institute. Surveillance Epidemiology and End
Results. Stat Fact Sheets: Acute Lymphocytic Leukemia.

    [3] Pieters R et al. Cancer, 2010 Sep 7 (Epub ahead of print).
    * In those countries where ERWINASE is authorized for use.
    ** Not all products are approved currently for use in the U.S.

    Contacts
    Bryan Morton
    Chief Executive
    EUSA Pharma
    Tel: +44(0)1865-784255

    Rob Budge
    RJB Communications
    Tel: +44(0)1865-760969
    Mobile: +44(0)7710-741241

SOURCE EUSA Pharma


Source: newswire